1. 6th Annual
Biosimilars Conference
Revolutionizing biosimilars market - debates, challenges and innovations
2nd - 4th March 2010, Boston, USA BOOK NOW!
Key Speakers
Tina S. Morris, Vice President, Biologics and Biotechnology, United States Pharmacopeial Convention
Yining Zhao, Associate Research Fellow, Strategy Management Group, Pfizer
Dr. David L. Gollaher, President and Chief Executive Officer, California Healthcare Institute
Les Jordan, CTO, Life Sciences Industry Unit, Microsoft
Terry Hisey, Vice Chairman, U.S. Life Sciences Leader, Deloitte LLP
James Harris, CEO, Healthcare Economics LLC
Clifford S. Mintz, Founder, BioInsights
Mateja Urlep, Director, TikhePharma
Dr Duu-Gong Wu, Executive Director, Pharmanet
Brian J. Del Buono, Director, Sterne, Kessler, Goldstein & Fox
Dr. Fethi Trabelsi, Director, Scientific & Regulatory Affairs, Anapharm
Roger Lias, President, Eden Biodesign
Senior Representative, Paraxel Consulting
Pre conference Workshop, Tuesday 2nd March 2010
Creating confidence in a new wave of biologics therapy - Overcoming barriers to entry
led by: Gil Bashe, Executive Vice President, Health Practice, Makovsky + Company
Media Partners
Driving the Industry Forward | www.futurepharmaus.com Organised By
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/biosimilarsusa

2. Conference Introduction
6th Annual Biosimilars Conference
2nd – 4th March 2010, Boston, USA
“The US biosimilar market, generating $0.06bn sales in 2008, will Media Partners:
achieve significant revenues only after expected implementation of PharmiWeb.com is the leading industry-sponsored portal for
a biosimilar regulatory pathway in 2013, visiongain predicts. If this
occurs, the US biosimilar market will increase to annual revenues of the pharmaceutical sector. Supported by most of the leading
$1.95bn in 2014” (Source: Visiongain Report ‘Biosimilars and Follow-on pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features,
Biologics 2009-2024’ Published: April 2009) events listings and international jobs to industry professionals across Europe and the US.
For further information please email: corporate@pharmiweb.com
Dear Colleague,
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD.
Biologics constitutes a major share of expenditure in the USA and globally. It is one of the It is based and located in Warsaw, Poland. Biotechnology World was
fastest growing sectors of the pharmaceutical industry which corresponds to over 15% founded in 2007 to provide the world’s biotech and pharma information and market to
of the total pharmaceutical market. make it universally accessible and useful for scientific and business processes. Its first step
There is a large and potentially lucrative demand for lower cost biological drugs to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will
worldwide.With favourable regulatory developments, the biosimilar sector should pick allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers
up significantly, however, forming an important developing pharma market. companies completed internet public relations, publication and marketing solutions. One of
Visiongain’s 6th Annual Biosimilars Conference will feature keynote addresses, the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector
presentations, case studies and interactive discussions from regulatory issues to in Europe to global biotechnology, pharmaceutical and life science activities.
manufacturing process, clinical assessment, commercialization and pricing. For further information please visit www.biotechnology-europe.com
Future Pharmaceuticals has forged powerful relationships with
Driving the Industry Forward | www.futurepharmaus.com
This three day event is an ideal forum for experts from the industry and academy sector
together to discuss and share their experience and best practices. key industry leaders to provide a platform for successful brand
recognition, and for senior decision-makers to have the means to procure and plan
Why Attend? implementation strategies based on the topics covered. Positioned to be an authoritative
resource within top pharma companies as well as small, specialty, and biotech, Future
• Discover the key strategies for process development/manufacturing of biosimilars
Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted
• Discuss the key regulatory and scientific issues of biosimilars and follow-on biologics and responsive audience, bridging the gap between the industries’ top issues and the
• Examine commercialisation of biosimilars solutions top-tier vendors can provide.
• Understand the development and marketing of biosimilars For further information please visit: www.futurepharmaus.com
• Assessing impact of IT driven patient adherence methodologies on biologics and InPharm is the online platform for exclusive pharmaceutical news,
comment, contracts, services, jobs and events and is home to
biosimilars
InPharmjobs.com, Pharmafile and Pharmafocus.
• Learn how to develop and create strategic outsourcing strategies for biosimilars For further information please visit: www.In-Pharm.com
• Network and discuss ideas with the leaders in the field ‘Pharma Connections Worldwide® is the leading professional
I look forward to meeting you at the conference business networking website focused in the Pharmaceutical,
Best regards Biotechnology and Life Sciences research industry. Our goal is to provide a conduit for
delivery of premiere content coupled with the right clientele in order to facilitate business
development opportunities among industry professionals responsible for making key
decisions in a global marketplace. ‘
For further information please visit: www.pharmaconnections.com
Pranita Nangia
Conference Producer
Biosimilars and Follow-On Biologics Report:
The Global Outlook 2009-2024
A visiongain report
Who should attend?
Branded Biotechnology, Pharmaceuticals & Generic Pharmaceutical
Companies, Drug Regulators, Healthcare Agencies, Government About visiongain:
Departments, Contract Research/Bio manufacturing, Organisations,
Visiongain is a specialist business information company focused on providing cutting
Regulatory Affairs, Pharmacovigilance edge products and services across the Pharmaceutical/Biotech, Telecommunications,
VPs, Directors, Heads, Managers of: Defence and Finance sectors, which include reports, conferences, online daily news and
• Follow on Biologics/Follow on Proteins/Biosimilars offline news analysis and bespoke consultancy. With a commitment to innovation and
• Biologics/Biotechnology/ Biogenerics excellence, visiongain offers flexible solutions to meet our clients’ business intelligence
needs, providing the right information at the right time to facilitate the commercial
• Legal Affairs decision-making process. Our pharmaceutical products include Pharma Business Daily,
• Intellectual Property the leading daily email newsletter for the pharmaceutical, biotech and healthcare
• Health Economics industries, and a range of independent, high-quality, in-depth reports covering focused
• Pricing and Reimbursement and topical areas of concern. Our pharmaceutical conferences address the hottest
• Biopharmaceuticals/ Biotherapeutics commercial, regulatory and technical topics and provide an ideal forum for debate and
• Clinical Immunology networking for pharmaceutical professionals from around the world.
• Principal Scientist For further information, please visit: www.visiongain.com
• Payers
• Chief Scientific Officer
• Process Control and Analytical Technologies
• Analytical Characterisation Sponsorship and exhibition opportunities:
• Regulatory Compliance This event offers a unique opportunity to meet and do business with some of the key
• Pharmacovigilance players in the pharmaceutical and biotech industries. If you have a service or product to
• Drug Safety & Risk Management promote, you can do so at this event by:
• Quality Affairs/ Quality Control
• Hosting a networking drinks reception
• New Product Development
• Process Science • Taking an exhibition space at the conference
• Portfolio Management • Advertising in the delegate documentation pack
• Research & Development • Providing branded bags, pens, gifts, etc.
• Business Development If you would like more information on the range of sponsorship or exhibition possibilities for
• Business Operations visiongain's 6th Annual Biosimilars Conference, please contact us:
• Scientific Affairs
• Commercial Affairs Sandra Clout +44 (0)20 7549 9969
• Marketing sandra.clout@visiongainglobal.com

3. Pre-Conference Interactive Workshop
6th Annual Biosimilars Conference
Tuesday 2nd March 2010, Boston, USA
Creating confidence in a new wave of biologics therapy
- Overcoming barriers to entry
Led by: Gil Bashe, Executive Vice President, Makovsky + Co Timings: 09:30 - 10:00 Coffee & Registration
10:00 - 15:00 Workshop
Brian E. Harvey, MD, PhD, Vice President, Regulatory Policy, sanofi-aventis
Kristie Kuhl, JD, Senior Vice President, Makovsky + Company Timing includes lunch and refreshment breaks
Francis B. Palumbo, PhD, JD, Professor and Executive Director, University of
Maryland School of Pharmacy Center on Drugs and Public Policy
Agenda: About your workshop leaders:
Legislative pathways for biosimilar regulatory approval Gil Bashe, Executive Vice President, Makovsky + Co
may provide significant implementation confusion. The Workshop Leader
wrong path to biosimilar approval may jeopardize ability
to develop future advancements and place obstacles in the Mr. Bashe is counselor to pharmaceutical, biotechnology, medical-device
path to reducing healthcare costs. The debate on whether manufacturers and patient advocacy groups. He has advised clients on follow-
legislation is pro-innovator or biogenerics entrepreneur on-biologic (FOB) policies and reimbursement, first in Europe and now in the
may overshadow addressing key concerns for future United States. Mr. Bashe is a limited partner with GTCR Golder Rauner, one of
success. This workshop will summarize the key concerns the nation’s leading private-equity firms and was CEO of CommonHealth, a
and enable participants to tackle these issues. Discussions WPP Group company, having served as at sister-company Hill and Knowlton
include: as Worldwide Health Practice director overseeing policy, provider and product
communications.
• How much authority will FDA have to make case-by-case
approval decisions? Brian E. Harvey, MD, PhD, Vice President, Regulatory Policy,
• What should the clinical data requirements be sanofi-aventis
for approval, immunogenicity and subsequent Dr. Harvey leads the sanofi-aventis Corporate Regulatory Affairs (CRA) office
interchangeability? in Bethesda, Maryland and interacts with the Food and Drug Administration
• Class and product-specific naming (FDA), C-Path Institute and key industry representatives on behalf of sanofi-
aventis. He represents sanofi on PhRMA, Regulatory Affairs Coordination
• How should market exclusivity address ever greening? Committee, and BIO’s Regulatory Affairs Committee. Prior to joining sanofi, Dr.
• How does patent law affect FOBs entry into the market? Harvey worked at the FDA in CDRH, CBER and CDER centers for more than 11
years and worked on health issues in the U.S. Senate. Dr. Harvey completed
• What should the nomenclature system be to reduce
his Ph.D. in biochemistry and his M.D. degree at the University of Connecticut.
confusion and promote patient safety?
Kristie Kuhl, JD, Senior Vice President, Makovsky + Company
Kristie Kuhl provides counsel on issues that impact biotechnology,
specialty pharma, dietary supplements and medical devices. Her legal and
communication skills provide keen insight in bringing together communities
About: Makovsky + Co with diverse interests especially important in the FOB arena. She has provided
counsel on the issues surrounding biosimilar approvals in Europe including
communicating the differences between biosimilars and generic drugs.
Francis B. Palumbo, PhD, JD, Professor and Executive
Director, University of Maryland School of Pharmacy Center
on Drugs and Public Policy
Founded in 1979, Makovsky + Company is today one of the nation’s leading
independent global public relations consultancies. The firm attributes its Dr. Francis Palumbo is both a lawyer and registered pharmacist and
success to its original vision: that the Power of Specialized ThinkingTM is the approaches biosimilars with a unique perspective. He has a strong
best way to build reputation, sales and fair valuation for a client. Celebrating interest in pharmacy and food and drug law, pharmacoeconomics,
its 30th year in 2009, Makovsky has received numerous industry accolades pharmacoepidemiology and health services research. As an adjunct professor
including; the American Business Awards 2009 PR Agency of the Year and at the Maryland School of Law, he teaches a course in food and drug law,
Holmes Report 2009 Multispecialist Agency of the Year. Based in New York including content on foods, dietary supplements, drugs and other products
City, the firm has agency partners in more than 26 countries and in 35 U.S. regulated by the FDA and its sister agencies. Dr. Palumbo received his B.S. in
cities through IPREX, the third largest worldwide public relations agency Pharmacy from the Medical University of South Carolina, M.S. and Ph.D. in
partnership, of which Makovsky is a founder. Health Care Administration from the University of Mississippi and J.D. from
For further information, please visit: www.makovsky.com the University of Baltimore Law Center.

4. Day 1
6th Annual Biosimilars Conference
Wednesday 3rd March 2010, Boston, USA
09:30 Registration and refreshments 13:10 Networking lunch
10:00 Opening address from the chair 14:30 The impact of a patient centric viewpoint on
James Harris biosimilars
CEO
• Review of emerging PHR and patient centric healthcare information
Healthcare Economics LLC
technology (HIT) and how it applies to biosimilars
• Includes a discussion of the effect of IT driven patient adherence
10:10 Opportunities and challenges for biosimilars in the methodologies on biologics and biosimilars
global market
Les Jordan
• Assessing the promise and potential for biosimilars CTO, Life Sciences Industry Unit
Microsoft
• Latest progress in biosimilars development
• Regulatory update on bioequivalence, interchangeability and substitution
for biosimilars 15:10 Strategies for process development/manufacturing
• Provider perspectives and acceptance of biosimilars
of biosimilars (for global markets)
• The biosimilar CMC section - what does it look like?
• Payer perspectives and formulary acceptance
• Where (if anywhere) can time be saved when developing a biosimilar
• Examining the viability of biosimilars & ROI considerations
production process?
James Harris
• Derivation of cell lines and materials
CEO
Healthcare Economics LLC • The importance of analytics and comparability protocols
• Early mistakes can be expensive - what to be aware of
10:50 Commercializing biosimilars: Will they really be able Dr. Roger Lias
to compete? President
• Size and location of markets Eden Biodesign
• Manufacturing and distribution challenges
• Interchangability and substitution issues 15:50 Afternoon refreshments
• Branding and pricing concerns
• Market penetration and physician uptake 16:10 Presentation to be announced
Clifford S. Mintz Senior Representative
Founder Parexel
BioInsights
16:50 Acceptance criteria for immunogenicity of
11:30 Morning refreshments Biosimilars
• Assessing the risk of strategies of immunogenicity
11:50 Demystifying the market aspects/implications of • Evaluating the potential of immunogenetic response
follow on biologics
• Market positioning and attractiveness
17:30 Closing remarks from the chair
• Strategies
• Commercial operations
R.T. (Terry) Hisey
Vice Chairman and U.S. Life Sciences Leader
Deloitte LLP
17:35 Networking drinks
Take your discussions further and build new
relationships in a relaxed and informal setting.
12:30 Presentation to be announced
Dr. David L. Gollaher
President and Chief Executive Officer
California Healthcare Institute (CHI)
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2009

5. Day 2
6th Annual Biosimilars Conference
Thursday 4th March 2010, Boston, USA
09:30 Registration and refreshments 12:30 Trends and technical challenges for the development
of biosimilars in China
• Understanding the current competitive landscaping of China’s biosimilars market
10:00 Opening address from the chair
• Addressing the critical issues and gaps of China’s biologics R&D and
manufacturing capabilities
10:10 Role of USP standards in the quality assessment of • Discussing the trends and opportunities of the biosimilars/biobetters in China
biological medicines Yining Zhao
• Role of the official compendial and standard-setting process Associate Research Fellow, Strategy Management Group
Pfizer
• Value of public standards and monographs
James Leung
• Quality assessment of biological medicines Founder
• Analytical challenges and future developments James Leung Consulting
Tina S. Morris
Vice President, Biologics and Biotechnology 13:10 Networking lunch
United States Pharmacopeial Convention
14:30 Pharmacovigilance and risk management plans
• Evaluating key challenges
10:50 An overview on regulatory and scientific issues of
biosimiars and follow-on biologics • Thorough risk-benefit analysis
• Updates on regulatory and, scientific issues related to biosimilars and • Need for a robust pharmacovigilance plan
follow-on biologics
• Discussions on technical challenges for the approval of biosimilars/follow- 15:10 Biosimilars - Succeeding in the market of the future
on biologics
• From dream to reality
• Requirements of CMC, pre-clinical and clinical studies using examples of
• The global biosimilars market today
approved products in both US and Europe
• Lessons learned so far
Dr. Duu-Gong Wu
Executive Director, Consulting Division • Evolving business models
PharmaNet
• Delivering against the promise?
Mateja Urlep
11:30 Morning refreshments Founder, Tikhe Pharma
Former Global Head of Marketing and Medical, Sandoz
11:50 Legislative and regulatory developments impacting 15:50 Afternoon refreshments
the biologics and biosimilars marketplace
• Update on progress of biosimilars legislation through the U.S. House 16:10 Clinical Phase 1 PK/PD trials for
and Senate biosimilar/follow-on products
• Analysis of the provisions of the competing U.S. bills • The clinical comparability exercise
• Comparison of the proposed biosimilars legislation to small molecule • PK/PD studies for early efficacy and safety assessment
regulation under Hatch-Waxman
• Study design challenges with some particular specific biosimilars
• Views of affected constituencies (biopharma companies, generics
companies, health care providers, patients) Dr. Fethi Trabelsi
Director, Scientific & Regulatory Affairs
• Comparison of the proposed US regulatory scheme to those in other Anapharm
parts of the world (especially Europe and Japan)
Brian J. Del Buono 16:50 Presentation to be announced
Director
Sterne, Kessler, Goldstein & Fox
17:30 Chair’s closing remarks
17:40 End of Conference
* Invited

6. Registration Form
6th Annual Biosimilars Conference
2nd – 4th March 2010, Boston, USA
For multiple bookings
Photocopy this form Conf. code VG
Standard Prices
6th Annual Biosimilars Conference
Conference and workshop Fee: £1699
Conference only Fee: £1299
2nd - 4th March 2010
Workshop only Fee: £599
Boston, USA
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Distribution of your company’s promotional literature to all conference attendees
Fee: £999
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